A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological Parameters and Blood Parameters

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Cnoga Medical Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cnoga Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01196533
First received: August 29, 2010
Last updated: August 6, 2012
Last verified: September 2010
  Purpose
  1. Aim:

    The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices.

  2. Hypothesis:

Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.


Condition Intervention
Accuracy of the TensorTip Device Compared With Standard Hospital Physiology and Lab Measurements.
Device: Non invasive peripheral blood monitoring

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological and Blood Chemistry Parameters

Resource links provided by NLM:


Further study details as provided by Cnoga Medical Ltd.:

Primary Outcome Measures:
  • Comparison of the TensorTip accuracy against hospital periodical readings. [ Time Frame: app 2 minute for each recording. ] [ Designated as safety issue: No ]
    To validate the physiologic (BP, HR, Spo2, Perfusion, pCo2, pO2, SV and other physiology patrameters) and blood chemistry (Hgb,Hct, Glucose, and others blood chemistry parameters) with similar measures obtained simultanously with standard invasive techniques in hospitalized patients.


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non Invasive Monitoring
Single group of hospitalized cardiovascular patients.
Device: Non invasive peripheral blood monitoring
non invasive monitoring
Other Names:
  • Device: Non Invasive peripheral blood monitoring by the TensorTip a mounted fingertip light weight device
  • Invasive screening :
  • Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron. PLT, PH, PCO2, PO2, HCO3, SaO2 ,
  • Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C), TBiLi, LDL, HDL.
  • non invasive screening: Hemodynamics & live signs: Systolic, Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume,
  • chemistry: WBC, RBC, Hgb, HCT ,Iron. PLT, PH, PCO2, PO2, HCO3, SaO2 ,
  • Arms: Group A
  • Other Names:
  • CMIL-MHUS-V1.0
  • R10-04-007
  • Cnoga Medical Ltd.
  • TensorTip
  • SoftTouch
  • SofTouch

Detailed Description:

The TensorTip (previously named Soft Touch) is a novel non invasive Finger tip device that. The Tensor Tip is a non-invasive device which was designed and aimed to measure a wide range of physiological and bio-parameters such as blood glucose, hemoglobin and hematocrit, blood PH, oxygen saturation SpO2, blood carbon dioxide, blood pressure, peripheral pulse and more based on the temporarily color distribution of the tissue under consideration. The Tensor Tip is based on real time color image sensor, real time photographing the fingertip tissue. A color image sensor of the type used in the Tensor Tip enables a wide range of information in the spectral, resolution, dynamic range and time domains enabling further investigation of the blood chromatic changes as a function body physiology. The concept behind this investigation reflects the idea that a change in human physiology condition would temporarily change the blood pigmentation.

The present study is aimed to assess the accuracy of the novel device in measuring all the above mentioned parameters by recording AS IS the change of the fingertip color tissue while simultaneous recording the standard invasive measured parameters on daily or periodic routine in the hospitalized patients.

This vast data recordings (tissue and references) enable the Tensor tip to analyze a particular bio parameter. The tensor tip is calibrated to a certain bio parameter based on the vast data set collected.

The bio parameter under consideration are: Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron, PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),TBiLi, LDL, HDL.

This study hopes to demonstrate the connection between blood color pigmentation and certain bio parameters for simplifying monitoring procedure and particular home monitoring.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, age > 18
  2. Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.
  3. Patients receiving coronary artery bypass with or without valve repair.
  4. Able to sign an informed consent.

Exclusion Criteria:

  1. Refusal to sign an informed consent and to participate in the study.
  2. Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.
  3. Below the age of 18.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196533

Locations
United States, New Jersey
Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine
Morristown, New Jersey, United States, 07962-1905
Sponsors and Collaborators
Cnoga Medical Ltd.
Investigators
Principal Investigator: Frank Smart, M.D Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health
Study Chair: Yosef Segman, PhD Cnoga Medical Ltd.
Study Director: Donna Hesari, BSN Atlantic Health System, Department of Cardiovascular Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Cnoga Medical Ltd.
ClinicalTrials.gov Identifier: NCT01196533     History of Changes
Other Study ID Numbers: CMIL-MHUS-V1.0
Study First Received: August 29, 2010
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cnoga Medical Ltd.:
Non Invasive, Invasive, optical, light source, color image sensor,
, Hemodynamic, Arterial Systolic, Arterial Diastolic, MAP, PA Systolic,
PA Diastolic, Heart rate, Stroke volume, CBC, WBC, RBC, Hgb, HCT ,Iron.
PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),
TBiLi, LDL, HDL.

ClinicalTrials.gov processed this record on October 29, 2014